1. Field of the Invention (Technical Field)
This invention relates to an apparatus and method for the treatment of fecal incontinence wherein a fecal dam and fecal matter sensor are retained within the rectal vault to both prevent the passage of stool and to sense the occurrence of the filling of the rectal vault. When the sensor detects the presence of feces within the rectal vault, it signals the user or caregiver, allowing bowel management without the attendant need for diapers.
2. Description of Related Art
Fecal incontinence (FI) is the impaired ability to control stool. Although not a life-threatening disease, symptoms are often distressing and socially incapacitating. For patients who are under nursing care, there is a labor cost associated with disposing of fecal waste after a patient's incontinent episode and cleaning the patient after the event. Other problems include the possible excoriation of the patient's skin when it is exposed to fecal waste for significant amounts of time, and the risk of contamination for patients and nursing personnel from fecal material. Economically, the replacement of soiled bed linens, blankets and gowns compounds the loss of valuable nursing time and effort.
According to published reports, daily or weekly episodes of fecal incontinence occur in approximately 2% of the adult population and in about 7% of healthy, independent adults over the age of 65. Fecal incontinence is second only to dementia as the cause of institutionalization in the elderly and has been variously estimated to affect between 32% to 47% of all nursing home residents. In addition, FI accounts for expenses of over $400 million per year for adult diapers alone. The condition arises from a number of causes including spinal bifida, dementia, obstetric injury and side effects of anorectal surgery.
Minor degrees of fecal incontinence can be managed through diet. For some patients, surgery and/or biofeedback treatment has been used with success. For some patients, electrical stimulation may be used or an artificial sphincter may be surgically implanted. However, there are a large number of patients suffering from fecal incontinence for whom medical therapy and/or surgical therapy have either failed or are inappropriate due to the patient's medical condition, circumstances, or personal choice.
U.S. Pat. No. 4,686,985 (Lottick) discloses an anal dilator and occluder which has multiple chambers and which is inserted partially into the rectum and inflated, thereby serving a dual role of creating a controllable opening that can either block the passage of stool, or can be used to widen a narrow anus, allowing stool to pass. U.S. Pat. No. 4,979,947 (Berman) discloses an encapsulated expanding device that is coated in a gelatin capsule and is inserted into the rectum. When the gelatin capsule becomes moist, it dissolves, allowing a compressed foam to expand, thereby blocking the passage of stool. An attached string which comes out of a hole in the abdominal wall can then be used to adjust the position of the foam dam and allow feces to pass. The above two inventions do not disclose a means to alert the user as to the need to void the bowels. Since many patients suffer from nerve damage and cannot sense the need to evacuate the bowels, leakage or other undesirable effects may occur due to a prolonged retention of stool within the rectal vault.
U.S. Pat. No. 5,695,484 (Cox) discloses an adhesive patch for managing fecal incontinence by blocking seepage from the anus. U.S. Pat. No. 6,096,057 (Klingenstein) discloses a fecal incontinence device that uses external wings that are held in place in the cleft of the buttocks by an expandible member that is inserted into the rectum, with the combination said to block the passage of feces. The problem with these approaches is that they do not incorporate an alarming means to alert the user of the need to evacuate the bowels. Left unattended, the devices can lead to impaction of stool and attendant problems such as necrosis of tissues in the anus and rectum.
U.S. Pat. No. 4,813,422 (Fisher et al) discloses a bowel control probe apparatus and method for sensing and preventing incontinent episodes. A deflated balloon catheter is inserted into the rectal vault and is then inflated to serve as a dam to block the passage of stool. At the tip of the catheter assembly is an optical sensor that uses infrared technology to sense the presence of stool. When fecal matter presses into an optical emitter/detector sensor, it causes an alarm to alert the wearer or caregiver that the bowels need attention. One disadvantage of the device is that because fecal matter can cause permanent occlusion of the optical sensor, the device must be discarded after each use. For a patient who has multiple daily bowel movements, the cost can be prohibitive.
U.S. Provisional Patent Application Ser. No. 60/313,540 (Brady) proposes a bowel incontinence treatment device having a balloon catheter and annular electrode sensors to detect the presence of fecal material. The problem with the design is that annular electrodes are prone to nuisance tripping (false positives) upon insertion and during wear.
The present invention solves the problems of the prior art noted above.